title: Efficacy of coronary stenting versus balloon angioplasty in small coronary arteries. Stent Restenosis Study (STRESS) Investigators.
abstract: OBJECTIVE
  The goal of this study was to compare the efficacy of elective stent implantation and balloon angioplasty for new lesions in small coronary arteries.
  
  
  BACKGROUND
  Palmaz-Schatz stents have been designed and approved by the Food and Drug Administration for use in coronary arteries with diameters > or = 3.0 mm. The efficacy of elective stent placement in smaller vessels has not been determined.
  
  
  METHODS
  By quantitative coronary angiography, 331 patients in the Stent Restenosis Study (STRESS) I-II were determined to have a reference vessel < 3.0 mm in diameter. Of these, 163 patients were randomly assigned to stenting (mean diameter 2.69 +/- 0.21 mm), and 168 patients were assigned to angioplasty (mean diameter 2.64 +/- 0.24 mm). The primary end point was restenosis, defined as > or = 50% diameter stenosis at 6-month follow-up angiography. Clinical event rates at 1 year were assessed.
  
  
  RESULTS
  Baseline clinical and angiographic characteristics were similar in the two groups. Procedural success was achieved in 100% of patients assigned to stenting and in 92% of patients assigned to angioplasty (p < 0.001). Abrupt closure within 30 days occurred in 3.6% of patients in both groups. Compared with angioplasty, stenting conferred a significantly larger postprocedural lumen diameter (2.26 vs. 1.80 mm, p < 0.001) and a larger lumen at 6 months (1.54 vs. 1.27 mm, p < 0.001). Restenosis (> or = 50% diameter stenosis at follow-up) occurred in 34% of patients assigned to stenting and in 55% of patients assigned to angioplasty (p < 0.001). At 1 year, event-free survival was achieved in 78% of the stent group and in 67% of the angioplasty group (p = 0.019).
  
  
  CONCLUSIONS
  These findings suggest that elective stent placement provides superior angiographic and clinical outcomes than balloon angioplasty in vessels slightly smaller than 3 mm.
authors.affiliation: Division of Cardiology, Jefferson Medical College, Philadelphia, Pennsylvania 19107, USA.
authors.forename: M P
authors.initials: MP
authors.lastname: Savage
authors.forename: D L
authors.initials: DL
authors.lastname: Fischman
authors.forename: R
authors.initials: R
authors.lastname: Rake
authors.forename: M B
authors.initials: MB
authors.lastname: Leon
authors.forename: R A
authors.initials: RA
authors.lastname: Schatz
authors.forename: I
authors.initials: I
authors.lastname: Penn
authors.forename: M
authors.initials: M
authors.lastname: Nobuyoshi
authors.forename: J
authors.initials: J
authors.lastname: Moses
authors.forename: J
authors.initials: J
authors.lastname: Hirshfeld
authors.forename: R
authors.initials: R
authors.lastname: Heuser
authors.forename: D
authors.initials: D
authors.lastname: Baim
authors.forename: M
authors.initials: M
authors.lastname: Cleman
authors.forename: J
authors.initials: J
authors.lastname: Brinker
authors.forename: S
authors.initials: S
authors.lastname: Gebhardt
authors.forename: S
authors.initials: S
authors.lastname: Goldberg
mesh_terms: D015906:Angioplasty, Balloon, Coronary; D016009:Chi-Square Distribution; D015331:Cohort Studies; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D003331:Coronary Vessels / Q000473:pathology*; D018572:Disease-Free Survival; D017558:Elective Surgical Procedures; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D015607:Stents; D015996:Survival Rate; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration